Fluidic connector for irrigation and aspiration of wounds

ABSTRACT

Disclosed herein are several embodiments of a negative pressure apparatus and methods of using the same in the treatment of wounds. Some embodiments are directed towards improved fluidic connectors configured to transmit irrigation fluid and to apply aspiration to a wound, for example using softer, kink-free conformable layers. Some embodiments may comprise a first channel for delivering irrigation fluid to the wound and a second channel for transmitting negative pressure and removing fluid comprising irrigation fluid and wound exudate from the wound, wherein the channels comprise a flexible spacer material. Some embodiments are directed toward an irrigation manifold attachable to or incorporated as part of a distal end of an irrigation and aspiration fluidic connector.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/822,254, filed May 10, 2013, the entirety of which is herebyincorporated by reference.

BACKGROUND Field of the Invention

Embodiments described herein relate to apparatuses, systems, and methodsthe treatment of wounds, for example by applying irrigation andaspiration to a wound via a fluidic connector.

Description of the Related Art

The treatment of open or chronic wounds that are too large tospontaneously close or otherwise fail to heal by means of applyingnegative pressure to the site of the wound is well known in the art.Negative pressure wound therapy (NPWT) systems currently known in theart commonly involve placing a cover that is impermeable orsemi-permeable to fluids over the wound, using various means to seal thecover to the tissue of the patient surrounding the wound, and connectinga source of negative pressure (such as a vacuum pump) to the cover in amanner so that negative pressure is created and maintained under thecover. It is believed that such negative pressures promote wound healingby facilitating the formation of granulation tissue at the wound siteand assisting the body's normal inflammatory process whilesimultaneously removing excess fluid, which may contain adversecytokines bacteria. However, further improvements in NPWT are needed tofully realize the benefits of treatment.

In previously filed U.S. Pat. Nos. 7,524,315 and 8,105,295, theentireties of each of which are hereby incorporated by reference,apparatuses, wound dressings, and methods for aspirating, irrigating andcleansing wounds are described. In some of the embodiments describedtherein, a wound is treated by the application of topical negativepressure (TNP) therapy for aspirating the wound, together with thefurther provision of additional fluid for irrigating and/or cleansingthe wound, which fluid, comprising both wound exudates and irrigationfluid, is then drawn off by the aspiration. The aspiration andirrigation are typically provided via conduits passing through thedressing into the wound cavity.

Whilst such treatment methods work well in practice, the stiffness ofthe aspiration and irrigation conduits in such close proximity to thewound site can adversely affect the healing process. Patient movement orpressure onto the wound dressing may bring the healing wound intocontact with the relatively inflexible conduits. Such force can causedisturbance of a wound bed which can damage a wound site. This canpotentially cause delays in healing of the wound site. These conduitscan also cause discomfort to the patient. The ability to create a fluidtight seal about the area where the conduits pass through the wounddressing can also be challenging.

It will also be appreciated that aspiration and irrigation conduits areprone to obstruction. The conduits may become obstructed by movement ofthe patient, which may cause part of the tube to bend and form a kink ormay place pressure onto the tubing, substantially or fully blocking theflow of fluid through the tubing. This can reduce or eliminate thenegative pressure and/or irrigation fluid being transmitted to the woundsite. In embodiments employing a separate canister for fluid collection,obstruction of the aspirant conduit can also result in accumulation ofexcess wound exudate at the wound site.

SUMMARY OF THE INVENTION

Certain embodiments disclosed herein relate to improved fluidicconnectors for providing aspiration and irrigation and having enhancedflexibility. Such fluidic connectors may have advantages over prior artdressings which may be more rigid and therefore uncomfortable for apatient, particularly when inserted into or located around sensitivewound areas. Other advantages may be that the fluidic connectorsdescribed herein are less prone to obstruction than the more rigidconduits of the prior art. Also disclosed are improved methods of useand systems for use of the same, preferably in conjunction with negativepressure wound therapy.

In one embodiment, a fluidic connector for providing aspiration andirrigation to a wound site, comprises:

-   -   a proximal end and a distal end and an elongate length extending        therebetween;    -   a top layer, a bottom layer and an intermediate layer each        constructed from a flexible, liquid impermeable material and        adhered to one another, wherein each of the layers has a        proximal end and a distal end and elongate portions extending        therebetween;    -   an upper fluid passage between the top layer and the        intermediate layer;    -   a lower fluid passage between the intermediate layer and the        bottom layer;    -   one or more openings at or near a distal end of the upper fluid        passage; and    -   one or more openings at or near a distal end of the lower fluid        passage;    -   wherein each of the upper and lower fluid passages comprises a        flexible, elongate spacer material between corresponding layers;        and    -   wherein one of the upper and lower fluid passages is configured        to provide aspiration to the wound site, and the other of the        upper and lower fluid passages is configured to provide        irrigation fluid to the wound site.

In further embodiments, the spacer material of each of the upper andlower fluid passages may comprise at least one of a 3D knitted or 3Dfabric material, foam, a porous material and non-woven material. Theupper fluid passage configured to provide aspiration to the wound andthe lower fluid passage may also be configured to provide irrigationfluid to the wound. The one or more openings at or near a distal end ofthe upper fluid passage may comprise an upwardly facing opening in thetop layer. The one or more openings at or near a distal end of the upperfluid passage may comprise a distally facing opening between the top andintermediate layers. The spacer material of the upper fluid passage mayextend distally beyond the distally facing opening between the top andintermediate layers. The one or more openings at or near a distal end ofthe lower fluid passage may comprise a plurality of microporous openingsin the bottom layer. Some embodiments can further comprise a fluiddistributing layer positioned below the one or more openings at or neara distal end of the lower fluid passage. A distal end of the spacermaterial of the lower fluid passage may extend distally beyond a distalend of the spacer material of the upper fluid passage.

In further embodiments, the fluid passage configured to provideirrigation fluid to the wound site may comprise a plurality of radiallyextending arms at a distal end thereof. Some embodiments may compriseplurality of openings along each of the radially extending arms. Theradially extending arms may comprise spacer material therein. Theradially extending arms may be formed in part by the bottom layer. Theradially extending arms may be part of a manifold attached to the bottomlayer with the radially extending arms in fluid communication with theone or more openings at or near the distal end of the lower fluidpassage.

Some embodiments may further comprise adhesive along at least a portionof the bottom layer for adhering the bottom layer to skin adjacent awound. The corresponding layers of each of the upper and lower fluidpassages may have side portions along sides of the elongate spacermaterial that are parallel to and adhered to each other. The fluidicconnector is sufficiently soft to conform to a patient's skin along asubstantial portion of a length of the fluidic connector.

In another embodiment, a method of treating a wound of a patient,comprises:

-   -   positioning the fluidic connector of any one of the preceding        claims into a wound with the one or more openings of the upper        and lower fluid passages positioned within the wound and the        proximal end of the fluidic connector positioned outside of the        wound with a portion of the fluidic connector positioned against        the skin of the patient;    -   covering the wound with a wound cover, wherein the wound cover        is sealed to skin surrounding the wound and seals against the        portion of the fluidic connector positioned against the skin of        the patient;    -   providing negative pressure to the wound through one of the        upper and lower fluid passages; and    -   providing irrigation fluid to the wound through the other of the        upper and lower fluid passages.

Further embodiments may further comprise positioning a porous woundfiller into contact with the wound, and positioning the distal end ofthe fluidic connector over the porous wound filler. Some embodiments mayfurther comprise positioning a porous wound filler over the distal endof the fluidic connector, and positioning the wound cover over theporous wound filler that is positioned over the distal end of thefluidic connector.

In another embodiment, a system for treatment of a wound comprises:

-   -   a sealing membrane for covering the wound;    -   a dressing adapted to be positioned in the wound; and    -   a fluidic connector capable of being operably associated, in        use, with the wound cavity, the fluidic connector comprising:        -   a proximal end and a distal end and an elongate length            extending therebetween;        -   a first layer of flexible film,        -   a second layer of flexible film sealed around a perimeter to            the first layer of flexible film, thereby defining an            aspirant channel, wherein at least one aspiration opening in            the distal end of the first layer of flexible film is            configured to transmit aspiration to the wound cavity, and        -   a third layer of flexible film sealed around a perimeter to            the second layer of flexible film, thereby defining an            irrigation channel, wherein at least one irrigation opening            in the distal end of the third layer is configured to            transmit irrigation fluid to the wound.

In further embodiments, each of the aspirant channel and irrigationchannel may comprise a flexible, elongate spacer material betweencorresponding layers. The spacer material may extend through the atleast one aspiration opening.

In further embodiments, an aspirant conduit may be provided at theproximal end of the aspirant channel. A vacuum means may be configuredto apply negative pressure to the wound through the aspirant conduit andthe aspirant channel. A waste collection canister may be configured toconnect to a proximal end of the aspirant conduit. An irrigation conduitmay be provided at the proximal end of the irrigation channel. Anirrigation source may be configured to provide irrigation fluid to thewound through the irrigation conduit and the irrigation channel.

Further embodiments may comprise a manifold attached over the at leastone irrigation orifice, the manifold having a lower surface, themanifold adapted to deliver irrigation fluid across a larger area thanthe distal end of the irrigation opening. The manifold may comprise aplurality of radially extending arms. Each of the plurality of radiallyextending arms may comprise a plurality of irrigation orifices in thelower surface. The wound filler may comprise first and second layers ofa wound filling material, and wherein the distal end of the fluidicconnector is positioned between the first and second layers of woundfilling material.

In another embodiment, a fluidic connector for providing aspiration andirrigation to a wound site, may comprise:

-   -   a top layer and a bottom layer each constructed from a flexible,        liquid impermeable material, wherein each of the layers has a        proximal end and a distal end and elongate portions extending        therebetween, and wherein each of the layers has a left edge and        a right edge and a center portion therebetween;    -   a left seal extending along the length of the left edges of the        top and bottom layers, a right seal extending along the length        of the right edges of the top and bottom layers, and a middle        seal extending along at least a portion of the length of the        center portions of the top and bottom layers;    -   a left fluid passage between the top and bottom layers, further        defined by the left seal and the middle seal;    -   a right fluid passage between the top and bottom layers, further        defined by the middle seal and the right seal;    -   one or more openings in the bottom layer at or near a distal end        of the left and right fluid passages; and    -   at least one applicator portion attached to or integral with the        bottom layer at a distal end of the bottom layer;    -   wherein each of the left and right fluid passages comprises a        flexible, elongate spacer material between the top and bottom        layers; and    -   wherein one of the left and right fluid passages is configured        to provide aspiration to the wound site, and the other of the        left and right fluid passages is configured to provide        irrigation fluid to the wound site.

In another embodiment, a fluidic connector for providing aspiration andirrigation to a wound site, may comprise:

-   -   a proximal end and a distal end and an elongate length extending        therebetween;    -   a first fluid passage and a second fluid passage positioned        side-by-side and joined together along at least a portion of the        elongate length, each of the fluid passages containing an        elongate spacer material; and    -   at least one applicator portion at the distal end;    -   wherein the first fluid passage is configured to provide        aspiration to a wound site, and the second fluid passage is        configured to provide irrigation fluid to the wound site.

In further embodiments, the first fluid passage and the second fluidpassage may be separated at the distal end, each fluid passage beingconnected to a separate applicator portion. The first fluid passage andthe second fluid passage may be formed between flexible layers of liquidimpermeable material.

In another embodiment, a method of treating a wound of a patient, maycomprise:

-   -   positioning a wound cover over a wound, wherein the wound cover        seals to skin surrounding the wound;    -   positioning a fluidic connector as described above over an        opening in the wound cover;    -   providing negative pressure to the wound through one of the        fluid passages; and    -   providing irrigation fluid to the wound through the other of the        fluid passages.

In another embodiment, a system for treatment of a wound, may comprise:

-   -   a sealing membrane for covering the wound;    -   a wound filler adapted to be positioned in the wound; and    -   a fluidic connector as described above configured to be sealed        over an opening in the sealing membrane.

Further embodiments may comprise a source of negative pressureconfigured to be in fluid communication with one of the fluid passages,and a source of irrigation fluid configured to be in fluid communicationwith the other of the fluid passages.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates an embodiment of a negative pressure wound treatmentsystem capable of aspirating and irrigating a wound;

FIG. 1B illustrates an embodiment of a negative pressure wound treatmentsystem capable of aspirating and irrigating a wound;

FIG. 2 illustrates a cross sectional view of an embodiment of a fluidicconnector for irrigation and aspiration used with a negative pressurewound treatment system;

FIG. 3A illustrates a top view of an embodiment of a fluidic connectorfor irrigation and aspiration of wounds;

FIG. 3B illustrates a bottom view of an embodiment of a fluidicconnector for irrigation and aspiration of wounds;

FIG. 3C illustrates an exploded view of the layers of an embodiment of afluidic connector for irrigation and aspiration of wounds;

FIG. 3D illustrates an exploded view of the layers of an embodiment of afluidic connector with an integrated manifold;

FIG. 3E illustrates a cross sectional view of one end of an embodimentof a fluidic connector for irrigation and aspiration of wounds;

FIG. 4A illustrates a top view of an embodiment of a manifold for usewith an irrigation fluidic connector;

FIG. 4B illustrates a bottom view of an embodiment of a manifold for usewith an irrigation fluidic connector;

FIG. 5A illustrates a top view of an embodiment of a manifold attachedto a fluidic connector for irrigation and aspiration of wounds;

FIG. 5B illustrates a bottom view of an embodiment of a manifoldattached to a fluidic connector for irrigation and aspiration of wounds;

FIG. 5C illustrates a cross sectional side view of a manifold attachedto a fluidic connector for irrigation and aspiration of wounds;

FIG. 6 illustrates a cross sectional view of an embodiment of a fluidicconnector for irrigation and aspiration of wounds having a flat lowerlayer;

FIG. 7 illustrates an embodiment of a fluidic connector for irrigationand aspiration of wounds having the layers sealed in the middle of theheight of the fluidic connector; and

FIGS. 8A-D illustrate various views of an embodiment of a fluidicconnector for irrigation and aspiration of wounds having side-by-sidechannels.

DETAILED DESCRIPTION

Preferred embodiments disclosed herein relate to wound therapy for ahuman or animal body. Therefore, any reference to a wound herein canrefer to a wound on a human or animal body, and any reference to a bodyherein can refer to a human or animal body. The term “wound” as usedherein, in addition to having its broad ordinary meaning, includes anybody part of a patient that may be treated using negative pressure.Wounds include, but are not limited to, open wounds, incisions,lacerations, abrasions, contusions, burns, diabetic ulcers, pressureulcers, stoma, surgical wounds, trauma and venous ulcers or the like.Treatment of such wounds can be performed using negative pressure woundtherapy, wherein a reduced or negative pressure can be applied to thewound to facilitate and promote healing of the wound. It will also beappreciated that the negative pressure systems and methods as disclosedherein may be applied to other parts of the body, and are notnecessarily limited to treatment of wounds.

With reference initially to FIGS. 1A-B, treatment of a wound in certainembodiments of the application uses a system 100 comprising a therapyunit 110, a fluidic connector 125 having an elongate bridge portion 130extending between a proximal end 145 and a distal end 150, a manifold140 at the distal end 150, a wound filler 160 and a drape 170. A singleconduit 120 (FIG. 1A) or multiple conduits 122, 124 (FIG. 1B) may beutilized to connect the fluidic connector 125 to the therapy unit 110.

The wound may be filled with a filling or packing material 160. Suitablematerials for the wound filler 160 may be porous, pressure resistantmaterials which resists crushing at negative pressures of a maximum ofabout −250 mmHg below atmospheric, and materials which may also serve tomaintain a uniform pressure distribution over the area of the wound.Such materials are known to those skilled in the art and may includeGazetex™ gauze bandage roll supplied by Derma Sciences Inc., CAVICARE™supplied by Smith & Nephew, open cell reticulated polyurethane foam,polyvinyl alcohol foam, Mepitel™ supplied by Molnlycke, or compressedfoam, for example. As described further below, multiple wound fillersmay be used, for example a first wound filler that is placed in contactwith the wound and a second wound filler that may be placed over thefluidic connector 125.

In some embodiments, as illustrated in FIG. 1A, the fluidic connector125 may be configured to be placed in the wound, either above and/orunder one or more wound fillers 160. As described in further detailbelow, the fluidic connector 125 is configured to provide deliver bothaspiration and irrigation to the wound. As illustrated, a conduit 120with at least two interior channels or lumens (one for aspiration, onefor irrigation) may connect the proximal end of the elongate bridge 130of the fluidic connector to an integrated therapy unit 110. Theintegrated therapy unit 110 may contain means for providing negativepressure, such as a vacuum pump, and means for supplying irrigationfluid. For example, an integrated unit could be an irrigation andaspiration unit such as Ulta™ supplied by KCl. In other embodiments,separate irrigation and aspiration units may be provided.

Over the wound filler 160 and fluidic connector 125 is the drape 170.The drape 170 may be a flexible film, for example polyurethane. With theelongate bridge 130 of the fluidic connector 125 positioned against theskin surrounding the wound, the drape 170 may be laid over the wound andsealed to the patient's healthy skin surrounding the wound, creating asubstantially sealed wound cavity to which negative pressure may betransmitted. The drape 170 is therefore also laid over the elongatebridge 130 of the fluidic connector 125, forming a seal with an uppersurface of the elongate bridge as well as the skin on both sides of theelongate bridge. In some embodiments, a lower surface of the fluidicconnector 125 may also be sealed to the patient's skin. For example,adhesive may be applied under the fluidic connector 125 prior toplacement of the connector over the patient's healthy skin, or may beprovided along the elongate bridge 130 during manufacture and protectedprior to use by a release layer. The drape 170 and/or fluidic connector125 may be effectively sealed to the patient's healthy skin surroundingthe wound by means of an adhesive on the wound-facing lower surface ofthe drape, for example a pressure-sensitive adhesive. However, the term“sealed” is not an absolute requirement nor practically attainable sincemany flexible drape membrane materials are composed of semi-permeableplastics materials which are well known to those skilled in the art. Theterm semi-permeable is defined as being permeable to water vapour andgases but not liquids or air, having a transmissibility of moisturevapour greater than approximately 500 g/sq·m/per 24 hr period.Furthermore, there is almost inevitably some leakage between the skin towhich the sealing drape is adhered due to hairs and/or other skinsurface irregularities and/or imperfections which are not easilycompletely sealed in absolute terms. Examples of the types ofself-adhesive, flexible dressing drape materials which are ordinarilyused in TNP type therapy as sealing membranes over and around wounds arelisted hereinabove and are well known to those skilled in the art andwill not be elaborated on further herein unless necessary.

Some embodiments may employ separate units for irrigation andaspiration, as illustrated in FIG. 1B. For example, an aspirant conduit122 may enable fluid communication between the proximal end of thefluidic connector 125 and a pump 104 for generating aspiration at thewound site. Liquid comprising wound exudate and/or irrigation fluid maybe carried away from the wound through the aspirant conduit 122. A wastecanister 102 may optionally be disposed between the fluidic connector130 and the pump 104 for collection of fluid, for example irrigationfluid and wound exudates, which has been removed from the wound site. Insome embodiments, the canister 102 may be integrated into the pump 104.However, in other embodiments, the wound filler 160 may act as a wastecanister to collect and store wound exudate removed from a wound sitebeneath the drape 170.

An irrigation conduit 124 may enable fluid communication between theproximal end of the fluidic connector 125 and an irrigation source 106.Irrigation fluid from the irrigation source may be drawn into the woundusing the same pump 104 that provides aspiration through conduit 122, ora separate irrigation pump may also be used. Further arrangements forproviding aspiration and irrigation to the wound, as well as othersystems, apparatuses and methods that may be incorporated with thefeatures described herein, are described in U.S. Pat. Nos. 7,524,315 and8,105,295, the entireties of each of which are hereby incorporated byreference.

FIG. 2 illustrates a cross sectional view of a wound site 200 comprisinga wound cavity 210 packed with a first wound filling layer 162, abovewhich is located a fluidic connector 125 similar to what's shown in FIG.1A. The fluidic connector comprises an irrigation manifold 140 locatedat a distal end 150 of an elongate bridge 130, wherein the elongatebridge 130 comprises an irrigation channel 132 and an aspiration channel134. As illustrated and as further described below, in some embodimentsthe aspiration channel is an upper channel above a lower irrigationchannel, though in other embodiments this arrangement can be reversed,or the channels could be side-by-side. A second wound filling layer 164is positioned above the fluidic connector and the cavity 210 is sealedwith a flexible drape 170. With the elongate bridge of the fluidicconnector 125 positioned against the skin surrounding the wound, thedrape 170 may be laid over the wound and the elongate bridge, and may besealed to the upper surface and sides of the elongate bridge and thepatient's healthy skin surrounding the wound, for example by means of apressures sensitive adhesive provided on the lower (wound facing)surface of the drape. Sealing the drape to the bridge and the healthyskin may create a substantially sealed wound cavity to which negativepressure may be transmitted. In other embodiments, the drape maycomprise an upper layer and a lower layer, and the fluidic connector mayextend between the upper and lower layers.

As illustrated the wound may be filled with two layers of packingmaterial 162, 164, and the distal end 150 of the fluidic connector andthe manifold 140 may be disposed between the two layers. The manifold140 may be in fluid communication with the irrigation channel 132 at thedistal end 150 of the elongate bridge 130, and as illustrated may beprovided below the irrigation channel 132 to distribute irrigation fluidto the wound. However, in some embodiments such as shown in FIGS. 3A-3Cdescribed below, the distal end 150 of the fluidic connector may beadapted to provide irrigation fluid to the cavity 210, and the lowermanifold may be optionally not included. The lower surface of thefluidic connector distal end 150 or manifold 140 may provide irrigationfluid through at least one orifice by means of irrigation channel 132,as described further below.

Using irrigation fluid that passes through the irrigation channel 132,the lower wound filler 162 in contact with the wound cavity surface 210may be irrigated with fluid beneficial for the healing process. Negativepressure may be applied to the wound site through the aspiration channel132 and distributed through the upper wound filler 164 which maysubstantially fill the wound. In some embodiments, the lower woundfilling layer 162 may be a thin sheet shaped to line the wound surface,and the upper wound filling layer 164 may be shaped to maintain asubstantially flat surface approximately level with the patient'shealthy skin when the wound cavity is under negative pressure. In someembodiments, as described further below, the wound site may be aspiratedthrough at least one orifice at the distal end of the fluidic connector150.

The drape 170 may be placed over the bridge portion 130 andsubstantially seal to the top surface and sides of the bridge portionand the exposed healthy skin of the patient. The drape may seal, forexample, by a pressure-sensitive adhesive provided on the lower surfaceof the drape. The substantially sealed drape 170 and wound cavitysurface 210 define a wound cavity which may be provided with negativepressure.

FIGS. 3A-C illustrate an embodiment of a fluidic connector 300 which maybe used in the systems of FIGS. 1A-B and for treatment of a wound cavitysuch as in FIG. 2. In these embodiments, the fluidic connector does nothave a separate manifold such as manifold 140 described above. FIG. 3Aillustrates a top view of the fluidic connector 300, FIG. 3B illustratesa bottom view of the fluidic connector 300, and FIG. 3C illustrates anexploded view of the fluidic connector 300.

The fluidic connector 300 may comprise an elongate bridge portion 310and an enlarged rounded (e.g. circular) end 320. The distal end of thefluidic connector is depicted as having an enlarged circular shape,although it will be appreciated that any suitable shape may be used andthat the distal end need not be enlarged. The fluidic connector 300 maycomprise a sealed perimeter 330 defining one or more fluid transmissionchannels.

The fluidic connector 300 may comprise multiple layers of a flexiblefilm material sealed to one another in a perimeter 330. As shown in FIG.3C, a three layer structure may be provided, comprising a bottom layer334, an intermediate layer 333, and a top layer 332 to form an upperfluid passage and a lower fluid passage. Each of these layers may bemade of a flexible film, and in some embodiments may be transparent.Some embodiments of the flexible film may be formed from a soft polymer,for example a polyethylene, a polyvinyl chloride, a silicone orpolyurethane having a hardness of 30 to 90 on the Shore A scale.

At the distal end of the fluidic connector, the top layer may have anopening 352 through which aspiration to the wound can be provided. Alsoat the distal end of the fluidic connector, the bottom layer may haveone or more openings 354 for providing irrigation to the wound. Incertain embodiments, the lower surface of the enlarged end 320 of thelower film layer 334 may be provided with an adhesive for attaching to amanifold, as described below, or simply for attaching the lower surfaceto skin surrounding the wound.

The top, intermediate, and bottom film layers 332, 333, 334 may besubstantially the same shape as one another, and may each comprise anelongate bridge portion and an enlarged (e.g., rounded or circular)portion at a distal end thereof. Alternatively, the layers need not havethe same shape, and in one embodiment, the intermediate and bottomlayers may have a larger distal end than the top layer to provide agreater area to distribute irrigation to the wound.

The top layer 332 may be sealed to one or both of the intermediate layer333 and the bottom later 334, for example by heat welding, radiofrequency welding, laser welding, or ultrasonic welding. In someembodiments, the bottom layer 334 may be substantially flat and the toplayer 332 and intermediate layer 333 may be slightly larger than thebottom layer 334 in order to accommodate the height of the spacer layers(described below) and seal to the bottom layer. Such an arrangement isalso shown with respect to FIG. 6. In other embodiments, the top layer332 and bottom layer 334 may be substantially the same size and may beslightly larger than the intermediate layer 333, and the layers may besealed together approximately at the middle of the height of the fluidicconnector 300 such that the intermediate layer 333 is substantiallyflat. Such an arrangement is also shown with respect to FIG. 7.

In some embodiments, the elongate bridge portions of the film layers mayhave a length of 10 cm (or about 10 cm) or more, more preferably alength of 20 cm (or about 20 cm) or more and in some embodiments, may beabout 69 cm (or 27 cm) long. Some embodiments of the entire fluidicconnector, from a proximalmost edge of the top and bottom layers to adistalmost edge of the top and bottom layers, may be between 20 cm and80 cm (or about 20 cm to about 80 cm) long, more preferably about 60 cmand 80 cm (or between about 60 cm and about 80 cm) long, for exampleabout 70 cm long. In some embodiments, the elongate bridge portion ofthe flexible film layers may have a width of between 1 cm and 4 cm (orbetween about 1 cm and about 4 cm), and in one embodiment, is about 2.5cm wide. The ratio of the length of the elongate bridge portion to thewidth may in some embodiments exceed 6:1, and may more preferably exceed8:1 or even 10:1. The diameter of the circular portion may be about 3.5cm in some embodiments, or may be much larger to better distributeaspiration and irrigation to the wound.

The fluidic connector may comprise a first spacer layer 342 and secondspacer layer 344, the first spacer 342 layer positioned between the toplayer 332 and the intermediate layer 333 and the second spacer layer 344positioned between the intermediate layer 333 and the bottom layer 334.In some embodiments, the first spacer layer may be used as an aspirantlayer and the lower spacer layer may be used to transmit irrigationfluid. The aspirant spacer layer 342 may optionally comprise a hole 353located beneath the hole 352 in the top film layer 332 to facilitatetransmission of negative pressure.

The spacer layers may be made of any suitable material, for examplematerial resistant to collapsing in at least one direction, therebyenabling effective transmission of negative pressure or irrigation fluidtherethrough. In particular, the spacer layers ensure that an openchannel can be maintained to communicate negative pressure or irrigationfluid through the fluidic connector 300 to the wound area. The spacerlayer 342 should remain open under the typical pressures that will beapplied during negative pressure wound therapy. The spacer layers arepreferably formed of a material having a three dimensional structure.For example, a knitted or woven spacer fabric (for example Baltex 7970weft knitted polyester) or a non-woven fabric could be used. The spacerlayers may also comprise materials such foams, including open-cell foamssuch as polyethylene or polyurethane foam, meshes, non-woven materials,and fluid channels.

In some embodiments, each of the spacer layers 342, 344 may comprise a3D polyester spacer fabric layer including a top layer (that is to say,a layer distal from the wound-bed in use) which is a 84/144 texturedpolyester, and a bottom layer (that is to say, a layer which liesproximate to the wound bed in use) which is a 10 denier flat polyesterand a third layer formed sandwiched between these two layers which is aregion defined by a knitted polyester viscose, cellulose or the likemonofilament fiber. Other materials and other linear mass densities offiber could of course be used.

Some embodiments of the fluidic connector 300 may employ the same fabricfor both the upper and lower spacer layers 342, 344. However, in otherembodiments, a first material may be used as a spacer layer for theaspirant channel and a second material may be used as a spacer layer forthe irrigation channel, the first and second materials having propertiesoptimized for the purpose of aspiration or irrigation, respectively.Alternatively, some embodiments may utilize spacer fabric only for theaspirant channel so that the channel remains open even under negativepressure, and the irrigation channel may simply comprise a fluid passageencapsulated by the surrounding film layers.

Although the illustrated embodiment has been generally described ashaving an upper aspirant channel and a lower irrigation channel, it willbe appreciated that many variations of this configuration are possible.For example, some embodiments may employ more than two fluidtransmission channels. Other embodiments may only employ an irrigationchannel. In some embodiments the fluid transmission channels may be sideby side, or the irrigation channel may be above the aspirant channel.

In some embodiments, the elongated bridge of the spacer layers 342, 344may have dimensions in the same ranges as the bridge portions of thefilm layers described above though slightly smaller, and in oneembodiment is about 25.5 cm long and about 1.5 cm wide. Similarly, thediameter of the enlarged distal portion 320 of the spacer layers may beslightly smaller than the diameters of the enlarged ends of the filmlayers, and in one embodiment is about 2 cm. Some embodiments of aspacer layer may have adhesive on one or both of its proximal and distalends (e.g., one or more dabs of adhesive) in order to secure the spacerlayer to one or both of the adjacent film layers. Adhesive may also beprovided along a portion or the entire length of one or both of thespacer layers. In other embodiments, one or both of the spacer layersmay be freely movable within the sealed chamber of the adjacent filmlayers.

Some embodiments may optionally comprise a first conduit 362 and asecond conduit 364 at the proximal end of the elongate bridge portion310 of the fluidic connector 300. In some embodiments, the first conduit362 may be in fluid communication with spacer layer 342, and maytransmit fluid including irrigation fluid and wound exudates away from awound site through orifice 352, as well as providing negative pressureto the wound site. The second conduit 364 may be in fluid communicationwith spacer layer 344, and may transmit irrigation fluid through aplurality of holes 354 located in the lower film layer 334. In someembodiments, an optional fluid distributing layer 355 can be positionedbelow the plurality of holes 354 in the lower film layer 334 to aid ineven distribution of fluid across part of all of a wound site. Forexample, fluid distributing layer 355 can be a perforated film ormicroporous layer such as polyurethane foamed film or compressed foam.Fluid distributing layer 355 can be welded to, glued to, or laminatedover the lower surface of the lower film layer 334 below the pluralityof holes 354 in various embodiments. In some embodiments, fluiddistributing layer 355 can be pre-attached to the lower surface of thelower film layer 334. In other embodiments, the fluid distributing layer355 can be positioned between the lower surface of the lower film layer334 and a wound to be treated. As described above, in other embodimentssuch as shown in FIG. 1A, a single conduit having multiple lumens mayalso be utilized to transmit negative pressure and deliver irrigationfluid to the fluidic connector 300.

FIG. 3D illustrates an embodiment of a fluidic connector 300 in whichthe two layers of flexible film of the manifold 370 form part of theintermediate layer 333 and bottom layer 334. Thus, the intermediatelayer 333 and bottom layer 334 are shaped such that a manifold 370 issimply a part of the fluidic connector. The manifold top layer 372 isformed by the distal end of the intermediate layer 333, the manifoldspacer material 373 is formed by the distal end of the spacer layer 344,and the manifold bottom layer 374 is formed by the distal end of thebottom layer 334. A plurality of pores 375 may be provided in the lowermanifold layer 374 for distribution of irrigation fluids. The pores 375may cover substantially all of the surface of the manifold layer 374. Insuch embodiments, the spacer material 373 in the manifold may also bepart of the spacer material 344 of FIG. 3C. The manifold portion 373 ofthe spacer layer 334 extends distally past the end of the upper spacerlayer 342. In the illustrated embodiment, the manifold top layer 372,manifold spacer material 373, and manifold bottom layer 374 areintegrally formed as extensions of the intermediate film layer 333,spacer layer 344, and lower film layer 334 of the elongate bridgeportion 310, respectively. However, in other embodiments the manifold370 may be a separate structure attachable to a lower surface of thebottom film layer 334 of the elongate bridge portion 310, for example byadhesive or welding.

FIG. 3E illustrates a cross sectional view of one example arrangement ofthe conduits and flexible film layers at the proximal end of theelongate bridge portion 310 of the fluidic connector 300. Asillustrated, the intermediate film layer 333 is positioned underneaththe first conduit 362 and above the second conduit 364, however this canbe reversed in other embodiments. Accordingly, the first conduit 362 andthe second conduit 364 are positioned in a side-by-side configuration.The lower film layer 334 is positioned underneath the intermediate filmlayer 333 under the first conduit 362 and underneath the second conduit364. The upper film layer 332 is positioned above the first conduit 362and above the intermediate film layer 333 above the second conduit 364.Such a side-by-side configuration of the conduits 362, 364 can reducethe height of the fluidic connector compared to an arrangement in whichconduits 362, 364 are positioned above and below one another. Althoughthe conduits 362, 364 are arranged in a side-by-side configuration, theupper spacer layer 342 and lower spacer layer 344 with which conduits362, 364 (respectively) are in fluid communication can remain positionedabove and below one another.

FIGS. 4A-4B illustrate top and bottom views of an embodiment of amanifold 400 attachable to a fluidic connector, such as described inFIGS. 3A-C, or that may be incorporated as part of the fluidicconnector. The manifold may advantageously distribute the irrigationfluid over a larger area than the enlarged end of the fluidic connector.The manifold may comprise a plurality of radially extending arms 410. Insome embodiments, the arms 410 may be sized larger than a wound suchthat they may be made to fit the wound by folding the arms 410 back onthemselves. Other embodiments of the manifold may employ a variety ofother suitable shapes, including shapes with more or less radiallyextending arms, circular shapes, etc.

The manifold may comprise two layers of a flexible film such as used forthe fluidic connector described above, wherein the layers are sealedaround a perimeter. The encapsulated inner area of the manifold maycontain a layer of spacer fabric or other spacer material. Suitablematerials include those discussed above as well as reticulatedfiltration polyurethane foams with small apertures or pores. The topfilm layer of the manifold may be provided with a hole 420 for acceptingirrigation fluid from the fluidic connector. The hole 420 maycommunicate with the plurality of holes 354 of the fluidic connector300, or may communicate with a single larger hole at the enlarged end ofthe bottom layer of the fluidic connector 300.

As shown in FIG. 4B, some embodiments of the manifold may comprise anarray of holes 430 provided through the lower layer of the manifold foroutlet of irrigation fluid. Other embodiments may utilize differentconfigurations of holes than the illustrated embodiment, or may employ aporous membrane as the lower surface. For example, in some embodimentsthe holes 430, or pores or micropores used instead of or in addition tothe holes 430, may cover substantially all of the area of the radiallyextending arms 410. In some embodiments the holes 430, or pores ormicropores used instead of or in addition to the holes 430, may bearranged in regions of the radially extending arms 410 or in patternsover a portion of the area of the radially extending arms 410.

The holes or pores of the manifold may be sized or otherwise configuredin some embodiments so as to limit the maximum pressure at whichirrigation fluid may be delivered to a wound. The pores may also besized such that, at the desired flow rate, the fluid passes out of themanifold uniformly across its entire area, ensuring that the wound isuniformly irrigated. For example, some embodiments may limit thepressure of the fluid to approximately eight to twelve pounds per squareinch. This may be advantageous as fluids delivered at high pressures maydisturb the healing wound bed, and if the pressure exceeds approximately15 psi, bacteria may be pushed further into a patient's wound. In otherembodiments the irrigation fluid supply flow regulation may beaccomplished by other means, such as a pump and/or feed pressure.

FIG. 5A illustrates a top view of an embodiment of the fluidic connector300 of FIGS. 3A-C attached to the manifold 400 of FIGS. 4A-B. The upperlayer of the fluidic connector 300 has an orifice 352 for providingaspiration through the upper channel of the fluidic connector and fordrawing fluid away from a wound. FIG. 5B illustrates a bottom view thefluidic connector 300 attached to the manifold 400. The lower layer ofthe manifold is provided with a plurality of orifices 430 fortransmitting irrigation fluid to the wound. Some embodiments may employvery fine pore size foams for the lower layer, for example materialsfelted by heat and compression to produce a dense, porous film. Themanifold may be attached to the fluidic connector during manufacture ofthe fluidic connector, such that the manifold is simply part of thefluidic connector. Alternatively, the manifold may be provided to a userseparately from the fluidic connector and may be attached to the fluidicconnector by the user. This may be advantageous to allow the user toselect different manifolds depending on the needs of the patient.

FIG. 5C illustrates a cross sectional side view of another embodiment ofthe fluidic connector 300 having a manifold 400. The upper film layer440 and lower perforated film layer 460 of the manifold 400 areillustrated, encapsulating spacer layer 450. In the embodimentillustrated, a portion 390 of the spacer fabric of the aspirant channelmay extend beyond the orifice in the top layer, advantageously reducingthe possibility of occlusion of the orifice 352. In such an embodiment,the distal end of the fluidic connector has a distally facing opening totransmit negative pressure to the wound.

FIG. 6 illustrates a cross sectional view of the elongated length of anembodiment of a fluidic connector 600 having a substantially flat lowerfilm layer 650, a lower spacer layer 640, an intermediate film layer630, an upper spacer layer 620, and an upper film layer 610. The upperand intermediate film layers 610, 630 are sealed together or weldedalong a perimeter 660 such that the intermediate film layer 630 isslightly larger than the lower film layer 650 to accommodate the heightof lower spacer layer 640, and the upper film layer 610 is slightlylarger than the intermediate film layer 630 to accommodate the heightsof both spacer layers as well as the height of the intermediate layer.

FIG. 7 illustrates a cross sectional view of the elongated length of anembodiment of a fluidic connector 700 having a lower film layer 750, alower spacer layer 740, a substantially flat intermediate film layer730, an upper spacer layer 720, and an upper film layer 710. The upperand intermediate film layers 710, 730 are sealed together or weldedalong a perimeter 760 such that the upper film layer 710 is slightlylarger than the intermediate film layer 750 to accommodate the height ofthe upper spacer layer 720. In a substantially symmetricalconfiguration, the lower and intermediate film layers 750, 730 areadhered along a perimeter 760 such that the lower film layer 750 isslightly larger than the intermediate film layer 750 to accommodate theheight of the lower spacer layer 740.

Advantageously, in the embodiments of FIGS. 6 and 7, the correspondinglayers of each of the upper and lower fluid passages have side portionsalong sides of the elongate spacer material that are parallel to andadhered to each other. This gives the fluidic connector a flattercross-sectional profile that decreases in dimension towards both sideedges to facilitate sealing of a drape over the fluidic connector.Because the spacer material between the corresponding layers isflexible, the fluidic connector is relatively soft, and is capable ofconforming to the contours of a patient's skin.

FIGS. 8A-D illustrate various views of an embodiment of a fluidicconnector 800 for irrigation and aspiration of wounds havingside-by-side channels 802, 803. As shown in the partial cross-sectionalview of FIG. 8A, a flexible drape 820 such as those discussed above maybe substantially sealed to the healthy skin of a patient surrounding awound bed 840. The wound bed 840 may contain a wound filler 830, such asfoam or gauze or other suitable material. In contrast to some of theembodiments described above, the fluidic connector 800 may be securedover at least one opening or orifice 810 in drape 820 to provide thewound cavity 840 with irrigation and negative pressure. The orifice 810may be pre-made in the drape, or may be made by the health practitioner.The fluidic connector 800 comprises an applicator portion 806 that maybe secured over the orifice 810 in the drape 820, and a flexible,elongate bridge portion 801 to connect the drape to sources of negativepressure and irrigation fluid, as described below. The elongate bridgeportion may optionally be sealed to the drape and/or skin surroundingthe wound using a suitable adhesive.

FIG. 8B illustrates a cross-sectional view of the fluidic connector 800taken along a portion of the elongate bridge portion 801. The fluidicconnector 800 may comprise a top layer 814 and a bottom layer 815, whichmay comprise flexible, liquid impermeable flexible films, such aspolyurethane. The top and bottom layers 814, 815 may be sealed around aperimeter 817 of the fluidic connector, for example by heat welding.Extending along at least a portion of the length of the fluidicconnector is middle separation portion 816, which creates a rightchannel 803 and a left channel 802 in the sealed top and bottom layers.Though the middle separation 816 is depicted at the center of the widthof the fluidic connector, thus creating two equally sized right and leftchannels, it will be appreciated that in some embodiments the middleseparation may be located more to one side or the other, therebycreating a right and left channel of different sizes. In someembodiments, the middle separation 816 may be a weld between the top andbottom layers. In other embodiments, the middle separation may be avertically-extending layer connected at its lower end to the bottomlayer 815 and at its upper end to the top layer 814.

The right and left channels shown in FIG. 8B each contain an elongatespacer material 812, 813. In some embodiments these may be the samematerial, while in other embodiments they may comprise differentmaterials. For example, in one embodiment the spacer material 813 of theleft channel 802 may comprise 3D fabric for transmission of negativepressure and aspiration of exudate, while the spacer material 812 of theright channel 803 may comprise open celled foam for transmission ofirrigation fluid. In other embodiments the left channel 802 may be usedfor irrigation and comprise foam as the spacer material 813, and theright channel 803 may be used for aspiration and comprise 3D fabric asthe spacer material 812. Other suitable materials for the spacermaterial are described with respect to the previous embodiments above.

As illustrated in FIG. 8C, the side-by-side channels 802, 803 may bejoined along a right side of the left channel 802 and a left side of theright channel 803 for the entire length of the fluidic connector 800.Some embodiments may form both channels out of two flexible film layerswith a middle seal between the two layers used to separate the channels,for example a heat weld which runs down the center of the two layers asdescribed above. The side-by-side channels 802, 803 may be connected toa single applicator flange portion 806. The applicator flange portion806 may be secured to a lower surface of the distal end of the fluidicconnector (e.g., secured to bottom layer 815), for example by heatwelding or adhesive. In some embodiments, the applicator flange portionmay merely be an extension of a lower layer (e.g., bottom layer 815) ofthe side-by-side channels 802, 803. The applicator flange portion 806may be a layer of flexible film, and may have a pressure-sensitiveadhesive provided on the lower surface thereof for sealing the fluidicconnector 800 to a drape 820. In some embodiments, the adhesive layermay be protected prior to use by a removable protective layer (notillustrated) which may be peeled off to expose the adhesive. Each of theside-by-side channels 802, 803 may have an orifice 804, 805 located onthe lower surface of a distal end thereof for delivery of fluid oraspiration through the at least one orifice 810 in the drape 820. Theapplicator flange portion 806 may have a hole or holes which correspondto the orifices 804,805. In some embodiments, each of the channelorifices 804, 805 may be located over a separate orifice in the drape820.

As illustrated by FIG. 8D, the side-by-side channels 802, 803 may bejoined along a right side of the left channel 802 and a left side of theright channel 803 for only a portion of the length of the fluidicconnector 800, and then may separate and connect to two separateapplicator flange portions 806. Although the separated fluidic connectoris depicted as a “Y” shape, it will be appreciated that manyconfigurations are possible, for example one channel may remain straightwhile the other is bent. Some embodiments of the fluidic connector maybe formed with a separated portion as illustrated, while someembodiments may be formed fully joined and may be separated as neededfor use, for example by being pulled apart for the desired length.

One of the side-by-side channels 802, 803 may provide irrigation fluidto the wound. The other of the side-by-side channels 802, 803 maytransmit negative pressure to the wound as well as aspirate fluid, whichmay comprise irrigation fluid and wound exudate, away from the wound. Insome embodiments, the channels may be used simultaneously. In otherembodiments, use of the channels may be alternated. For example,negative pressure may be provided to the wound cavity through theaspirant channel, and the wound may continue to receive negativepressure therapy for a first period of time. Irrigation fluid may thenbe provided to the wound through the irrigation channel and may beallowed to sit in the wound for a second period of time. After thesecond period of time, the aspirant channel may then be used to removethe irrigation fluid (and any wound exudate) and again initiate negativepressure in the wound cavity. This cycle may be repeated as needed, andit will be appreciated that although the example given began with aperiod of negative pressure, either negative pressure or irrigation maybe used for the first cycle. This cyclic irrigation/aspiration processmay be useful for bolus irrigation.

Additionally, some embodiments of the above-described aspiration andirrigation conduits may provide a means for venting air or a pressuremonitoring line. For example, some embodiments may include a vent holein the top layer of one of the two channels of the fluidic connector,for example at the proximal end of the elongate bridge. Otherembodiments employ a third conduit or vent channel in the elongatebridge portion, the third conduit in fluid communication with a ventorifice. The vent orifice may be at the proximate end of the bridgeportion, and may be provided with a filter. The vent channel may beprovided with a spacer fabric, such as any of the spacer fabricsdescribed above. Other embodiments may accomplish venting by means of astandalone vent port over a hole in the sealing drape.

In some embodiments, the third conduit or vent channel may be used as aseparate pressure monitoring conduit. In other embodiments, the thirdconduit may be used to alternately vent and measure pressure. Theconduit may switch between venting and pressure monitoring at regularintervals, or may switch in a controlled manner based on one or moreparameters of the negative pressure system. In embodiments whichalternate venting and pressure monitoring, air may be vented into to thewound for a first specified time period, for example via a valveattached to the third conduit; the valve may then be closed, thuspreventing air from entering the negative pressure system and a pressurereading may be taken, for example via a pressure sensor fluidicallyattached to the third conduit. Once a stable pressure reading has beenmeasured, or after a second specified period of time has passed, thevalve may be opened and the cycle repeated. In some embodiments, thefirst specified time period may be 1-600 seconds, or approximately 1 toapproximately 600 seconds, and the second specified time period may be0.1-60 seconds, or approximately 0.1 second to approximately 60 seconds.Vent flows may be of the order 0.1 to 10 liters per minute, orapproximately 0.1 to approximately 10 liters per minute. The addition ofa vent may advantageously help to stabilize the pressure at the wound byminimizing the amount of liquid present in the main aspirant conduit andreducing the possibility of blockage formation.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example describedherein unless incompatible therewith. All of the features disclosed inthis specification (including any accompanying claims, abstract anddrawings), and/or all of the steps of any method or process sodisclosed, may be combined in any combination, except combinations whereat least some of such features and/or steps are mutually exclusive. Theprotection is not restricted to the details of any foregoingembodiments. The protection extends to any novel one, or any novelcombination, of the features disclosed in this specification (includingany accompanying claims, abstract and drawings), or to any novel one, orany novel combination, of the steps of any method or process sodisclosed.

While certain embodiments have been described, these embodiments havebeen presented by way of example only, and are not intended to limit thescope of protection. Indeed, the novel methods and systems describedherein may be embodied in a variety of other forms. Furthermore, variousomissions, substitutions and changes in the form of the methods andsystems described herein may be made. Those skilled in the art willappreciate that in some embodiments, the actual steps taken in theprocesses illustrated and/or disclosed may differ from those shown inthe figures. Depending on the embodiment, certain of the steps describedabove may be removed, others may be added. Furthermore, the features andattributes of the specific embodiments disclosed above may be combinedin different ways to form additional embodiments, all of which fallwithin the scope of the present disclosure.

Although the present disclosure includes certain embodiments, examplesand applications, it will be understood by those skilled in the art thatthe present disclosure extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and obviousmodifications and equivalents thereof, including embodiments which donot provide all of the features and advantages set forth herein.Accordingly, the scope of the present disclosure is not intended to belimited by the specific disclosures of preferred embodiments herein, andmay be defined by claims as presented herein or as presented in thefuture.

1.-20. (canceled)
 21. A system for treatment of a wound, comprising: asealing membrane for covering the wound; a wound filler adapted to bepositioned in the wound; and a fluidic connector capable of beingoperably associated, in use, with the wound, the fluidic connectorcomprising: a proximal end and a distal end and an elongate lengthextending therebetween; a first layer of flexible film, a second layerof flexible film sealed around a perimeter to the first layer offlexible film, thereby defining an aspirant channel, wherein at leastone aspiration opening at or near the distal end of the first layer offlexible film is configured to transmit aspiration to the wound, and athird layer of flexible film sealed around a perimeter to the secondlayer of flexible film, thereby defining an irrigation channel, whereinat least one irrigation opening at or near the distal end of the thirdlayer is configured to transmit irrigation fluid to the wound, whereineach of the aspirant channel and irrigation channel comprises aflexible, elongate spacer material between corresponding layers. 22.(canceled)
 23. The system of claim 21, wherein the spacer materialextends through the at least one aspiration opening.
 24. The system ofclaim 21, wherein an aspirant conduit is provided at the proximal end ofthe aspirant channel.
 25. The system of claim 24, further comprisingvacuum means configured to apply negative pressure to the wound throughthe aspirant conduit and the aspirant channel.
 26. The system of claim24, further comprising a waste collection canister configured to connectto a proximal end of the aspirant conduit.
 27. The system of claim 21,wherein an irrigation conduit is provided at the proximal end of theirrigation channel.
 28. The system of claim 27, further comprising anirrigation source configured to provide irrigation fluid to the woundthrough the irrigation conduit and the irrigation channel.
 29. Thesystem of claim 21, further comprising a manifold attached over the atleast one irrigation opening, the manifold having a lower surface, themanifold adapted to deliver irrigation fluid across a larger area thanthe distal end of the irrigation channel.
 30. The system of claim 29,wherein the manifold comprises a plurality of radially extending arms.31. The system of claim 30, wherein each of the plurality of radiallyextending arms comprises a plurality of irrigation orifices in the lowersurface.
 32. The system of claim 21, wherein the wound filler comprisesfirst and second layers of a wound filling material, and wherein thedistal end of the fluidic connector is positioned between the first andsecond layers of wound filling material.
 33. A fluidic connector forproviding aspiration and irrigation to a wound site, comprising: a toplayer and a bottom layer each constructed from a flexible, liquidimpermeable material, wherein each of the layers has a proximal end anda distal end and elongate portions extending therebetween, and whereineach of the layers has a left edge and a right edge and a center portiontherebetween; a left seal extending along the length of the left edgesof the top and bottom layers, a right seal extending along the length ofthe right edges of the top and bottom layers, and a middle sealextending along at least a portion of the length of the center portionsof the top and bottom layers; a left fluid passage between the top andbottom layers, further defined by the left seal and the middle seal; aright fluid passage between the top and bottom layers, further definedby the middle seal and the right seal; one or more openings in thebottom layer at or near a distal end of the left and right fluidpassages; and at least one applicator portion attached to or integralwith the bottom layer at a distal end of the bottom layer; wherein eachof the left and right fluid passages comprises a flexible, elongatespacer material between the top and bottom layers; and wherein one ofthe left and right fluid passages is configured to provide aspiration tothe wound site, and the other of the left and right fluid passages isconfigured to provide irrigation fluid to the wound site.
 34. A fluidicconnector for providing aspiration and irrigation to a wound site,comprising: a proximal end and a distal end and an elongate lengthextending therebetween; a first fluid passage and a second fluid passagepositioned side-by-side and joined together along at least a portion ofthe elongate length, each of the fluid passages containing an elongatespacer material; and at least one applicator portion at the distal end;wherein the first fluid passage is configured to provide aspiration to awound site, and the second fluid passage is configured to provideirrigation fluid to the wound site.
 35. The fluidic connector of claim34, wherein the first fluid passage and the second fluid passage areseparated at the distal end, each fluid passage being connected to aseparate applicator portion.
 36. The fluidic connector of claim 34,wherein the first fluid passage and the second fluid passage are formedbetween flexible layers of liquid impermeable material.
 37. (canceled)38. A system for treatment of a wound, comprising: a sealing membranefor covering the wound; a wound filler adapted to be positioned in thewound; and a fluidic connector according to claim 33 configured to besealed over an opening in the sealing membrane.
 39. The system of claim38, further comprising a source of negative pressure configured to be influid communication with one of the fluid passages, and a source ofirrigation fluid configured to be in fluid communication with the otherof the fluid passages.
 40. A system for treatment of a wound,comprising: a sealing membrane for covering the wound; a wound filleradapted to be positioned in the wound; and a fluidic connector accordingto claim 34 configured to be sealed over an opening in the sealingmembrane.
 41. The system of claim 40, further comprising a source ofnegative pressure configured to be in fluid communication with one ofthe fluid passages, and a source of irrigation fluid configured to be influid communication with the other of the fluid passages.